CNK-UT009 cell injection in T1D
What this study tests
Recruiting Chinese investigator-initiated first-in-human study of CNK-UT009, a universal CAR-T / NKT cell product, in adults with autoimmune Type 1 diabetes who still have mixed-meal C-peptide of at least 0.2 nmol/L. Safety and MTD are the point. No results.
Editorial review: .
Registry checked: 2026-09-17. Registry’s own update: 2025-07-04.
Most recent recorded citation date: 2026-01-12. Only explicit date metadata is included; an undated citation may be newer. This does not mean every claim was reviewed on that date.
Trial status, labels and access can change between reviews. How we review the evidence · How to read the evidence
Evidence at a glance
- Who can enter the study?
- Adults 18–65 with autoimmune T1D, peak mixed-meal C-peptide at least 0.2 nmol/L (0.6 ng/mL), at least one islet autoantibody, and adequate marrow and organ function. Registered eligibility ↗Enrollment criteria describe who may enter. They do not establish who was analyzed or the denominator for a reported result.
- Reported benefit and results
- No results. Recruiting. ClinicalTrials.gov NCT07051564 lists estimated n=12, actual start 6 May 2025, primary completion 31 December 2026. ChiCTR2600116392 (registered 9 January 2026, last WHO refresh 12 January 2026) describes the same product as a universal CNK-UT009 injection with target n=18 in dose groups plus 5 in expansion. Dual registration is not two programmes, and neither record has posted outcomes.Read the result sources and their limitations →
- Important harms
- Read the reported results, safety discussion and original sources. A separate harms summary is not available; this does not establish safety.
- Research access and approval
- Study regions: Other regions. A trial listing does not establish product approval or current recruitment at a particular site. Check the study’s current entry requirements.
- What remains uncertain?
- Read the full discussion and original sources for study limitations. Planned endpoints and completion dates are not results.
Research status alone does not establish approval, clinical benefit or local availability.
Primary endpoints
- Safety and tolerability, including dose-limiting toxicity and maximum tolerated dose
- Change in mixed-meal stimulated C-peptide peak and AUC
The full picture
CNK-UT009 is described as a universal (off-the-shelf) CAR-T / NKT cell injection aimed at resetting autoimmunity, not as replacement islets. The Zibo Central Hospital investigator study is small, open-label and dose-finding. Mixed-meal C-peptide of at least 0.2 nmol/L (about 0.6 ng/mL) is an entry filter, so this is not a trial in people with no residual insulin production.
ClinicalTrials.gov lists the phase as N/A; that classification is retained here. The registry describes a single-arm, open-label, investigator-initiated study evaluating safety and tolerability and determining the maximum tolerated dose (MTD). The registry names Zibo Central Hospital as sponsor and names no product originator. An investigator-initiated cell-therapy protocol is not a ranked cure.
Sources
- [1]Clinical Study on the Treatment of Type 1 Diabetes With CNK-UT009 Cell Injection · Trial registry · 2025-07-04
- [2]CNK-UT009 cell injection in type 1 diabetes (ChiCTR2600116392) · Trial registry · 2026-01-12 — WHO ICTRP copy of the ChiCTR record; primary ChiCTR page was not fetchable as HTML from this environment.